Search CMI

What is in this leaflet

This leaflet answers some common questions about Biaxsig. It does not contain all
the available information.

It does not take the place of talking to your doctor and pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking
this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.

You may need to read it again.

What Biaxsig is used for

Biaxsig is used to treat infections in different parts of the body caused by bacteria.
For example:

acute pharyngitis (sore throat and discomfort when swallowing)

tonsillitis

sinusitis

acute bronchitis (infection of the bronchi causing coughing)

exacerbation of chronic bronchitis

pneumonia (lung infection characterised by fever, malaise, headache)

skin and soft tissue infections

non gonococcal urethritis

impetigo (bacterial infection causing sores on the skin)

Biaxsig is an antibiotic that belongs to a group of medicines called macrolides.

These antibiotics work by killing or stopping the growth of the bacteria that are
causing your infection.

Biaxsig, like other antibiotics, does not work against viral infections such as the
flu.

Your doctor may have prescribed Biaxsig for another reason. Ask your doctor if you
have any questions about why it has been prescribed for you.

This medicine is available only with a doctor's prescription.

This medicine is not addictive.

Before you take it

When you must not take it

Do not take Biaxsig if you have severe liver problems.

Do not take Biaxsig if you have an allergy to:

roxithromycin or any other macrolide antibiotic eg azithromycin, clarithromycin or
erythromycin.

any of the ingredients listed at the end of this leaflet (see Product Description)

Symptoms of an allergic reaction may include skin rash, itching, shortness of breath
or swelling of the face, lips or tongue which cause difficulty in swallowing or breathing.

Do not take Biaxsig if you are taking certain medicines for migraine headache called
ergot alkaloids eg Cafergot, Dihydergot; (not all brands listed).

Ask your doctor if you are not sure if you are taking one of these medicines.

Do not take it after the expiry date (EXP) printed on the pack.

If you take it after the expiry date has passed, it may not work as well.

Do not take it if the packaging is damaged or shows signs of tampering.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to any other substances, such
as foods, preservatives or dyes.

Tell your doctor or pharmacist if you are pregnant or intend to become pregnant.

Like most medicines of this kind, Biaxsig is not recommended for use during pregnancy.
Your doctor or pharmacist will discuss the risks and benefits of taking it if you
are pregnant.

Tell your doctor or pharmacist if you are breastfeeding or plan to breastfeed.

Biaxsig passes into breast milk. Your doctor or pharmacist will discuss the risks
and benefits of taking it if you are breastfeeding or planning to breastfeed.

Tell your doctor or pharmacist if you have or have ever had any other medical conditions,
especially the following:

kidney problems (impaired function)

liver problems (hepatic cirrhosis with jaundice and /or ascites).

Tell your doctor or pharmacist if you plan to have surgery.

If you have not told your doctor or pharmacist about any of the above, tell them before
you take Biaxsig.

Use in the Elderly

Biaxsig can be used in the elderly with no dosage adjustment required.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicines
that you buy without a prescription from your pharmacy, supermarket or health food
shop.

Some medicines may be affected by Biaxsig, or may affect how well Biaxsig works. These
include:

theophylline (Neulin), a medicine used to treat asthma

some medicines for migraine headache such as ergotamine (Cafergot)or dihydroergotamine
(Dihydergot tablets)

disopyramide (Rythmodan), a medicine to treat irregular heart rhythms

terfenadine and astemizole, over the counter medicines used to treat allergies

warfarin (Coumadin, Marevan), a medicine used to prevent blood clots

digoxin (Lanoxin, Sigmaxin), a medicine used to treat heart failure

midazolam (Hypnovel, Midazolam Sandoz), used to induce sleep before operations

ciclosporin (Neoral, Cicoral, Cysporin, Sandimmun), a medicine used to prevent organ
transplant rejection or to treat certain problems with the immune system

cisapride, a medicine used to treat gastrointestinal problems

pimozide (Orap), an antipsychotic medicine

These medicines may be affected by Biaxsig, or may affect how well it works. You may
need different amounts of your medicine, or you may need to take different medicines.
Your doctor or pharmacist will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or
avoid while taking Biaxsig.

How to take it

How much to take

The recommended adult dosage is 300 mg per day which may be taken according to one
of the following alternative dosage regimens:

one 300 mg tablet once a day, or

one 150 mg tablet twice a day, or

two 150 mg tablets once a day

However, depending on your condition and how you react to the medicine, your doctor
may ask you to take a different dose.

The recommended dosage for children more than 40 kg is one 150 mg tablet twice daily.

The dosage of Biaxsig given to children is dependent on the child's weight.

Ask your doctor or pharmacist if you are unsure of the correct dose for you.

They will tell you exactly how much to take.

Follow the instructions they give you.

If you take the wrong dose, Biaxsig may not work as well and your problem may not
improve.

How to take it

Swallow the tablets whole with a glass of water.

When to take it

Biaxsig should be taken at least 15 minutes before food or on an empty stomach (ie
more than 3 hours after a meal).

Biaxsig works best if you take it on an empty stomach.

How long to take it

For treating infections, Biaxsig is usually taken for 5 to 10 days.

However, your doctor may prescribe Biaxsig for longer periods.

Continue taking the tablets until you finish the pack or until your doctor or pharmacist
tells you to stop.

Ask your doctor or pharmacist if you are not sure how long to take the medicine for.

If you forget to take it

Do not try to make up for missed doses by taking more than one dose at a time.

This may increase the chance of getting an unwanted side effect.

If it is almost time for your next dose, skip the dose you missed and take the next
dose when you are meant to.

Do not take a double dose to make up for the dose you have missed.

If there is still a long time to go before your next dose, take it as soon as you
remember, and then go back to taking it as you would normally.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for
hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (13 11 26), or go
to the Emergency Department at your nearest hospital, if you think that you or anyone
else may have taken too much Biaxsig.

Do this even if there are no signs of discomfort or poisoning. You may need urgent
medical attention.

While you are taking it

Things you must do

If the symptoms of your infection do not improve within a few days, or if they become
worse, tell your doctor.

If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do
this even if it occurs several weeks after Biaxsig has been stopped.

Diarrhoea may mean that you have a serious condition affecting your bowel. You may
need urgent medical care. Do not take any diarrhoea medicine without first checking
with your doctor.

If you get a sore, white mouth or tongue while taking, or soon after stopping Biaxsig,
tell your doctor or pharmacist. Also tell your doctor or pharmacist if you get vaginal
itching or discharge.

This may mean you have a fungal/yeast infection called thrush. Sometimes the use of
Biaxsig allows fungi/yeast to grow and the above symptoms to occur. Biaxsig does not
work against fungi/yeast.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking
Biaxsig.

If you are about to start taking any new medicine, tell your doctor and pharmacist
that you are taking Biaxsig.

If you plan to have surgery that needs a general anaesthetic tell your doctor or dentist
that you are taking this medicine.

If you become pregnant while you are taking Biaxsig, tell your doctor or pharmacist
immediately.

Things you must not do

Do not take more than the recommended dose unless your doctor or pharmacist tells
you to.

Do not give this medicine to anyone else, even if they have the same condition as
you.

Do not use this medicine to treat any other complaints unless your doctor tells you
to.

Do not stop taking your tablets because you are feeling better, unless advised by
your doctor or pharmacist.

If you do not complete the full course prescribed by your doctor, all of the bacteria
causing your infection may not be killed. These bacteria may continue to grow and
multiply so that your infection may not clear completely or it may return.

Side Effects

All medicines have some unwanted side effects. Sometimes they are serious, but most
of the time they are not. Your doctor or pharmacist has weighed the risks of using
this medicine against the benefits they expect it will have for you.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Biaxsig.

It helps most people with bacterial infections, but it may have unwanted side effects
in a few people.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

oral thrush - white, furry, sore tongue and mouth

vaginal thrush - sore and itchy vagina and/or discharge

nausea, vomiting, stomach pain, indigestion, diarrhoea, flatulence

loss of appetite

red and/or itchy skin

headache, dizziness, ringing in the ears

hallucinations

confusion

tiredness

altered taste

rash

blurred vision and/or visual impairment

These side effects are usually mild and short-lived.

Tell your doctor or pharmacist immediately if you notice any of the following, particularly
if they occur several weeks after stopping treatment with Biaxsig:

severe abdominal cramps or stomach cramps

watery and severe diarrhoea, which may sometimes be bloody

fever, in combination with one or both of the above.

These are rare but serious side effects. You may have a serious condition affecting
your bowel. Therefore, you may need urgent medical attention.

Do not take any diarrhoea medicine without first checking with your doctor.

If any of the following happen, stop taking this medicine and tell your doctor immediately,
or go to Accident and Emergency at your nearest hospital: